CORE A: ABSTRACT Core A will be responsible for providing administrative and biostatistics support for the overall program project. The Core will interact with Program management at NIAID and with the external Scientific Advisory Panel, coordinating meetings and progress reports. Budget reports and annual reports to NIH and FDA will be coordinated by Core A. It will also serve to amalgamate the investigators, their experimental findings and their ideas, evaluation of pre- clinical and clinical efforts to focus efforts on enhancing the clinical outcome. The administrative functions will be accomplished using a structure in which the Core Leader, Dr. Riley, is advised by an Executive Committee of Project and Core Leaders with input from the Scientific Advisory Committee. The finances and meeting logistics of the U19 will be organized by Ms. Chelsey Molineaux who will meet monthly with the U19 PI and each Project and Core Leader. Dr. Shaw will provide comprehensive biostatistics support for the scientific project and core, and for the design and implementation of the clinical trial. Therefore, the specific aims are: SA1: To coordinate the interactions among scientists, private sector partners, and NIH personnel regarding efficient implementation of proposed plans and projects. SA2: To oversee all budgetary matters, including monitoring of monthly expenses and preparation of non-competitive renewal applications. SA3: To provide statistical support for projects, especially the proposed clinical trial in Project 4